A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 67
- Primary Endpoint
- Fusion
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this clinical trial is to assess the safety and effectiveness of the rhBMP-2/ACS/INTER FIX™ device as compared to the autograft/INTER FIX™ device in patients with symptomatic degenerative disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history (e.g., pain \[leg, back, or symptoms in the sciatic nerve distribution\], function deficit and/or neurological deficit) and radiographic studies (e.g., CT, MRI, X-Ray, etc.) to include one or more of the following:
- •instability (defined as angular motion \>=5° and/or translation \>= 4mm, based on Flex/Ext radiographs);
- •osteophyte formation;
- •decreased disc height;
- •thickening of ligamentous tissue;
- •disc degeneration or herniation; and/or
- •facet joint degeneration.
- •Has preoperative Oswestry score \>=
- •Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
- •Has single-level symptomatic degenerative involvement from L2 to S
Exclusion Criteria
- •Had previous spinal fusion surgical procedure at the involved level.
- •Has spinal instrumentation (which will not be removed) stabilizing the involved level.
- •Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
- •Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- •Has presence of active malignancy.
- •Has overt or active bacterial infection, either local or systemic.
- •Is grossly obese, i.e., weight\> 40% over ideal for their age and height.
- •Has fever (temperature\> 101°F oral) at the time of surgery.
- •Has a documented titanium alloy allergy or intolerance.
- •Is mentally incompetent. If questionable, obtain psychiatric consult.
Outcomes
Primary Outcomes
Fusion
Time Frame: 24 month
Fusion is defined as: 1. Evidence of bridging trabeculae. 2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs as determined by superimposing the two views, one upon the other. b. Less than 5° difference in angular motion between flexion and extension as seen on lateral flexion/extension radiographs. 3. No evidence of radiolucency surrounding greater than 50% of either device.
Pain/Disability Status
Time Frame: 24 month
The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score \>= 15
Neurological Status
Time Frame: 24 month
Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
Secondary Outcomes
- General Health Status (SF-36)(24 month)
- Hip (Donor Site) Pain(24 month)
- Disc Height Measurement(24 month)
- Pain Status (back pain, leg pain)(24 month)
- Patient Satisfaction(24 month)
- Patient Global Perceived Effect(24 month)